Ursodec

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What ursodeoxycholic acid is

Ursodeoxycholic acid (UDCA, also called ursodiol) is a naturally occurring secondary bile acid. Therapeutically it does three things at once: it displaces cytotoxic hydrophobic bile acids (chenodeoxycholic, deoxycholic, lithocholic) from the bile-acid pool, it reduces biliary cholesterol secretion (which dissolves cholesterol gallstones over months), and it protects cholangiocytes from bile-acid-mediated injury through cytoprotective and immunomodulatory effects. It is the only oral therapy with mortality and transplant-free survival benefit in primary biliary cholangitis (Poupon 1991, 1994; meta-analyses 2002, 2014).

Indicaties

• Primary biliary cholangitis (PBC) — first-line therapy; 13–15 mg/kg/day in divided doses with meals. ~60–70% biochemical response (alkaline phosphatase normalisation or significant fall) over 12 months. Non-responders are switched or augmented with obeticholic acid or fibrates.
• Cholesterol gallstone dissolution — for radiolucent stones < 15 mm in a functioning gallbladder, in patients who cannot or will not have cholecystectomy. 8–10 mg/kg/day for 6–24 months. Stone recurrence after cessation is significant (≈ 50% at 5 years).
• Primary sclerosing cholangitis (PSC) — improves biochemistry; mortality benefit not proven. High-dose (28–30 mg/kg/day) is associated with worse outcomes and is contraindicated.
• Intrahepatic cholestasis of pregnancy (ICP) — 10–15 mg/kg/day (or 500 mg twice daily); reduces maternal pruritus and bile acid levels; may reduce fetal complications.
• Non-alcoholic fatty liver disease (NAFLD) — biochemistry improves but high-quality histological benefit is unproven; not a first-line NAFLD therapy in current guidelines.
• Cystic fibrosis associated liver disease — used in paediatric and adult CF cholestasis.

Dosering

Bijwerkingen

Generally very well tolerated. Most common: mild diarrhoea (5–10%), abdominal discomfort, nausea, mild rash. Pruritus may transiently worsen in PBC during the first weeks before improving. Rarely: gallstone calcification (radio-opaque shift) on long courses.

Geneesmiddelinteracties

• Bile acid sequestrants (cholestyramine, colesevelam, colestipol) — bind UDCA in the gut and reduce absorption. Separate by ≥ 4–5 hours.
• Aluminium-containing antacids — bind UDCA. Separate by ≥ 2 hours.
• Oestrogens, oral contraceptives, clofibrate — increase biliary cholesterol saturation and antagonise the gallstone-dissolution effect.
• Ciprofloxacin, dapsone — modestly altered absorption; clinically minor.

Zwangerschap en borstvoeding

Used routinely off-label in intrahepatic cholestasis of pregnancy with extensive safety data. Compatible with breastfeeding (excreted in trace amounts in milk; no infant harm reported).

Opslag

Store below 25 °C in a dry place, original packaging. Tablets are stable for the full labelled shelf life when kept dry.

Waarom bestellen bij MedsBase

Ursodec is supplied through a WHO-GMP certified manufacturer with full COA documentation. We ship worldwide in plain, discreet packaging, and every order is covered by our Reshipment Assurance Policy. Your statement descriptor when paying by card shows the regulated payment processor (a regulated card-payment processor), never "MedsBase" or any medication name.

Veelgestelde vragen

How long until I see results in primary biliary cholangitis?

Alkaline phosphatase typically falls within 4–8 weeks and the trajectory at 12 months predicts long-term outcome. The Toronto, Paris-1 and Paris-2 criteria define a “biochemical responder” at 1 year by ALP, AST and bilirubin thresholds. Non-responders should discuss obeticholic acid or fibrate add-on with hepatology.

Can UDCA dissolve any kind of gallstone?

Only cholesterol stones, only if radiolucent on imaging, only in a functioning gallbladder, and only if < 15 mm. Calcified, pigment, or partially calcified stones do not respond.

Why does my doctor want me on UDCA forever for PBC?

PBC is a chronic autoimmune cholangitis. UDCA changes the disease trajectory but does not cure it. Stopping UDCA is followed by biochemical relapse within weeks. Lifelong therapy at 13–15 mg/kg/day is standard.

Can I take it during pregnancy?

Yes — UDCA is the standard treatment for intrahepatic cholestasis of pregnancy. Decades of use show no fetal harm, and it reduces maternal pruritus and bile acid levels.

Will UDCA cause weight loss or weight gain?

Neither, in most patients. Mild diarrhoea may cause minor early weight loss in a small fraction.

Does UDCA work for non-alcoholic fatty liver?

It improves biochemistry (ALT, AST). Whether it improves liver histology and outcomes is not established in large trials. Current NAFLD/NASH guidelines do not recommend UDCA as routine therapy.

Can I drink alcohol on UDCA?

Most patients on UDCA have an underlying liver condition. Alcohol is best avoided altogether in PBC, PSC and significant hepatic disease.

What is the difference between UDCA and bile salts in supplements?

UDCA is a specific bile acid (ursodeoxycholic). Generic “bile salt” supplements are mixtures of natural bile acids without therapeutic dose standardisation. Only purified UDCA tablets are used clinically for PBC and gallstone dissolution.

How is UDCA monitored?

For PBC: ALP, ALT, AST, GGT, total bilirubin every 3 months for the first year, then 6-monthly. For gallstone dissolution: ultrasound at 6, 12, and 24 months to track stone size.

Can high-dose UDCA be harmful?

In primary sclerosing cholangitis, doses ≥ 28 mg/kg/day were associated with WORSE clinical outcomes (Lindor 2009 NEJM). Stick to 13–15 mg/kg/day in PSC and never escalate without specialist input.

Other Liver & Hepatology Products

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